PIVOT - EDM

FDA Device Registration & Listing · La Vista, NE, US · Registration 3014903258

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014903258
FEI Number
3014903258
Entity Name
PIVOT - EDM
City/State/Country
La Vista, NE, US
Establishment Address
12202 Cary Circle, La Vista, NE 68128, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Pivot - EDM (Owner Number: 10061153)
Owner / Operator Contact Address
12202 Cary Circle, La Vista, NE 68128, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242804
PMA Number
N/A

All Registered Proprietary Names

Platform, Force-Measuring Zibrio Pro; Zibrio SmartScale 5020 Console; 5025 Console Otoscope Otoscope - WiscMed Wispr ASP-PUMP-120, PAL Aspiration Pump, 115V ASP-UI, PAL Aspiration Pump Console ASP-PUMP-240, PAL Aspiration Pump, 230V

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KHX Platform, Force-Measuring Physical Medicine Class 1 890.1575 2019-08-30
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2021-12-01
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2019-08-30
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2025-07-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pivot - EDM
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K932506 Rudolf Riester GmbH & Co. KG RI-SCOPE (S) 1993-10-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014903258. Last updated year: 2026. Please use registration number 3014903258 when referencing this establishment in official correspondence.
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